ISO 9000

Implementation
Tridash Chopra

ISO 9000: 1994 Clauses

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Management Responsibility
Quality System
Contract Review
Design Control
Document Control
Purchasing
Purchaser Supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing

ISO 9000: 1994 Clauses

11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

Inspection Measuring and Test Equipment

Inspection and Test Status
Control of Non-Conforming Product
Corrective Action
Handling, Storage, Packaging and Delivery
Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques

ISO 9000:2000 Clauses

1.
2.
3.
4.
5.

Quality Management System

Resource Management
Product or Service Realization
Management Responsibility
Measurement, Analysis and
Improvement

ISO 9000: 2000

Quality Management
System

Quality Management
System
Documentation
Standard
ISO 9000

Quality Manual
LEVEL 1

Policy Statement,
Commitment, Organisation,
Responsibilities

Quality System Procedures

Company Practices,
Interfaces

LEVEL 2

Work Instructions

Written
Instructions to
Control Tasks

LEVEL 3

Forms

Quality
Records

LEVEL 4

Sales

Desig
n

Purchasi
ng

Manufactu
ring

Accounts

Personn
el

After
Sales

Why have a Quality

Policy?

Need for Quality Policy

All organizations have in mind some

principles, beliefs which are their broad
guides to managerial conduct
These guides rest on a philosophical
and ethical base
They concern important issues and are
intended to have a long life, i.e. to act
as a stabilizer
Such principles and beliefs are referred
to as a Quality Policy

Need for Quality Policy

When organizations grow, there are

different managers working under which
various employees are working
Things need to be defined at that stage as
things start becoming ambiguous
As the unwelcome incidents accumulate,
there arises a growing urge to think
through, write out, and publish quality
policies to serve as guides to managerial
action

Advantages of Policies

It provides insiders and outsiders with a

new, superior form of predictability, i.e. a
written guide to managerial action
It forces the organization to think about
quality problems to a depth never before
achieved. before you write it down, you
must think it out
It establishes legitimacy and can be
communicated in an authoritative,
uniform manner
It permits practices to be audited against
that policy

Disadvantages of Policies

Major disadvantage is work involved

Some managers think that written
policies tend to restrict innovation
and to narrow the range of action
available to adapt to changing
conditions

Corporate Quality
Policies

As a company grows, it becomes evident that

no one set of quality policies can fit all
company activities
This problem is solved by creating several
levels of quality policy out of which one is
corporate policy which usually consists of

The purpose of writing and publishing quality

policies
A brief statement of corporate intent
The minimal actions to be taken by the company
divisions with respect to quality
Interdivisional relationships concerning quality
Relationship of quality policies to other company
policies

Corporate Quality
Policies

A delegation of authority to subordinate

company organization units to establish
subsidiary quality policies appropriate to
their needs
Summary statement

It is the policy of the company to provide

products and services of a quality that meet the
initial and continuing needs and expectations of
customers in relation to the price paid and to
the nature of competitive offerings, and in doing
so, to be the leader in product quality reputation

Corporate Quality
Policies

Importance of quality

Quality competitiveness

Leadership in quality has top priority

Quality shall be given equal priority to costs
and delivery
Equal or exceed competitive quality
Be of the highest quality

Customer relations

Provide customer satisfaction

Meet customer perception of good quality

Corporate Quality
Policies

Internal Customers

Work Force Involvement

We regard the receivers of our work results as

customers whose needs are important to
understand and satisfy
Our policy is to foster a spirit of pride among
employees regarding the companys quality
performance

Quality improvement

Resources will be allocated primarily to the

prevention of defects and corrective action will be
focused on rot-cause identification and elimination

Divisional Quality
Policies

The same design shall be used in all

factories making a specific product.
Quality of design shall be used in all
factories making a specific product

Quality Policies for

Functional Areas

Many of the policies are prepared to provide

guidance to managers in specific functional
departments such as product development,
manufacturing and marketing
New product introduction

Design reviews shall be conducted with customer,

market and regulatory bodies in order to ensure
the compliance of the design for quality

Suppliers

We seek to establish long-term, open relations with

our suppliers

Quality Policies for

Functional Areas

Manufacturing

Production

Manufacturing process capability must be

verified during the product development cycle
Involvement and a spirit of pride will be fostered
among employees by encouraging ideas and
resolutions regarding the companys quality
performance

Customer service

Service operations shall be conducted so as to

minimize customers shutdowns

Quality Objectives

An objective is an aimed-at-target
an achievement toward which effort
is extended.
Quality objective is an aimed-atquality target
Quality objectives should be
quantifiable in nature (measurable) SMART

Objectives vs. Policies

Objectives vs. Standards

Implementing ISO
9000:2000

Awareness Training
Establish a Team
Establish ISO 9000 Status
Prepare Action Plan
Track Action Plan
Present Status of Action Plan
ISO 9000 Readiness Assessment
Contact Registrar (Certification Body)
Official ISO 9000 Audit
Continuous Improvement
Celebrate!

ISO 9000:2000 Clauses

1.
2.
3.
4.
5.

Quality Management System

Resource Management
Product or Service Realization
Management Responsibility
Measurement, Analysis and
Improvement

Quality Management
System (QMS)

Concerned with the documentation

and management of the QMS
Sub-clauses:
Quality Manual
Control of documents
Control of records

Management
Responsibility

Concerned with the responsibility of

management in the implementation of the
quality system
Sub-clauses:

Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority, and communication
Management review

Resource Management

Concerned with the provision of

resources needed to implement the
QMS
Sub-clauses:
Provision of resources
Human resources
Infrastructure
Work environment

Product or Service
Realization

Concerned with the provision of processes to implement

the product or service
Sub-clauses:

Planning of product realization

Customer related processes
Customer requirements
Customer communication
Design and development
Control of changes
Purchasing process
Production and service provision
Validation of processes
Identification and traceability
Customer property
Preservation of product
Control of measuring and monitoring devices

Measurement, Analysis and

Improvement

Concerned with the establishment of a

measurement program to measure QMS
performance and to identify problems
Sub-clauses:

Measurement of customer satisfaction

Internal audits
Measurement and monitoring of processes
Measurement and monitoring of product
Control of nonconformity
Analysis of data
Continual improvement
Corrective action
Preventive action